UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001768 |
|---|---|
| Receipt number | R000002016 |
| Scientific Title | Usefullness of non-invasive biomarkers in the treatment wiht bronchial asthma |
| Date of disclosure of the study information | 2009/03/12 |
| Last modified on | 2009/03/12 11:03:37 |
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Basic information
Public title
Usefullness of non-invasive biomarkers in the treatment wiht bronchial asthma
Acronym
Non-invasive biomarkers in asthma treatment
Scientific Title
Usefullness of non-invasive biomarkers in the treatment wiht bronchial asthma
Scientific Title:Acronym
Non-invasive biomarkers in asthma treatment
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation between the non-invasive biomarker (impulse oscillometry, exhaled nitric oxide, quenstionnairs for QOL, etc) and routine respiratory function tests (spirometry, body plethysmography and closing volume) in patients with bronchial asthma. And we assess the efficacy and safty of these biomarkers in the treatment with mild asthma exacerbation using inhaled bronchodilator.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
1.Routine respiratory function tests: spirometry,body plethysmography and closing volume at atable period, before and 15min after inhaled bronchodilator during mild exacerbation.
2.Non-invasive biomarker; impulse oscillometry: R5,R20,R5-R20,X5,AX, and exhaled nitric oxide at stable period, before and 15min after inhaled bronchodilator during mild exacerbation.
Key secondary outcomes
Scores of questionnaires for QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Inhaled bronchodilator; salbutamol
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult mild and moderate persistent asthma treating with inhaled corticosteroids according to GINA2006 guideline
Key exclusion criteria
1. Obstructive pulmonary disease; COPD, bronchiectasis, choronic bbronchitis
2. Tuberculosis, other respiratory infection
3. Allergy for salbutamol
4. Pregnancy and lactation
5. Moderate and severe asthma exacerbation
6. inappropriate patients from the doctor's viewpoint
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tanaka |
Organization
Sapporo Medical University School of Medicne
Division name
Third Department of Internal Medicine
Zip code
Address
South-1, West-16, Chuo-ku, Sapporo 060-8543, Japan
TEL
011-611-2111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tanaka |
Organization
Sapporo Medical University School of Medicne
Division name
Third Department of Internal Medicine
Zip code
Address
South-1, West-16, Chuo-ku, Sapporo 060-8543, Japan
TEL
011-611-2111
Homepage URL
Sponsor or person
Institute
Third Department of Internal medicine, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Third Department of Internal medicine, Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2009 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 12 | Day |
Last modified on
| 2009 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002016
